1. Field of the Invention
The present disclosure relates to medicines, nutraceuticals, and medical devices (hereinafter collectively referred to as “medical products”) dispensing systems and methods. More particularly, the present disclosure relates to systems and methods for dispensing medical products from a vending machine using a self-selection algorithm and, in some embodiments, a de-selection algorithm, which eliminate the need for interaction between the purchaser and a licensed practitioner. Further, the present disclosure relates to methods of providing a risk management tool for switching prescription medical products to non-prescription, over-the-counter status. Still further, the present disclosure relates to systems and methods that provide greater access to over-the-counter medical products that have sales or distribution restrictions due to public safety and/or public health concerns.
2. Description of Related Art
Drugs, vaccines, biologics, and pharmaceutical products (hereinafter individually and collectively referred to as “medicines”) are commonly used to cure, treat and/or mitigate a variety of human and animal aliments and maladies. For purposes of dispensing these products in the United States, medicines are generally divided by Section 503(b)(1) of the Food, Drug, and Cosmetic Act into two classifications, namely prescription classification and a non-prescription classification. More specifically, the Food and Drug Administration (FDA) requires a prescription for the dispensing of any drug that is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. Thus, the FDA can designate a medicine with a non prescription status when the FDA finds that prescription dispensing is not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and the drug is safe and effective for use in self-medication as directed in proposed labeling.
Due to the highly regulated nature of medicines in the prescription classification, these prescription medicines are mostly dispensed from a licensed pharmacy. Typically, the medicines are controlled and stored in a restricted area of a pharmacy, namely behind-the-counter in the pharmacy, such that the dispensing of the medicine from a pharmacy can only be performed by or under the supervision of a pharmacist (hereinafter referred to as a “licensed practitioner”).
In contrast, and due to evidence that suggests that there are adequate controls and labeling in place for the safe and effective use in an over-the-counter setting, prescription medicines have typically been moved over-the-counter (OTC) from the restricted sales area and into the general sales areas in the pharmacy or other retail general sales location. As used herein, the term “general sales” area or location shall mean any area where access to the medicine is not restricted. As such, the general sales area or location can include the areas inside of a store, but not behind-the-counter of the pharmacy or behind-the-counter of the point-of-sale, and can include areas outside of the store.
In addition to the regulations placed on medicines by the FDA, the distribution of some medicines are also restricted or regulated by one or more federal and or state governmental agencies such as the Department of Justice (DOJ), the Drug Enforcement Agency (DEA) or individual State Boards of Pharmacy.
For example, pseudoephedrine (PSE) is a medicine that has non-prescription status, and is commonly used as a decongestant. However, PSE can also be used in the production of illicit and illegal drugs such as, but not limited to, methamphetamine. As such, governmental agencies have required that merchants or regulated sellers of PSE and PSE containing products regulate or restrict the distribution of PSE and PSE containing products. The restriction of PSE and PSE containing products typically includes moving the location of such products to a behind-the-counter setting in order to track the sales of such products. The compliance for documenting sales information and purchaser information is typically performed at the point-of-sale. Accordingly, although PSE is a non-prescription medicine, which would otherwise be made available in an over-the-counter setting, other agency regulations and distribution restrictions related to its sale have caused retailers to move this medicine to a behind-the-counter setting to capture the compliance information, Thus, state authorities have the ability to schedule any over-the-counter medicine and to move these medicines to a behind-the-counter setting for reasons of public health.
More recently, certain medicines have been classified as dual status medicines in the United States. Dual status medicines are medicines that have a non-prescription classification for certain portions of the population, but maintain a prescription classification for other portions of the population. For example, the emergency oral contraceptive Plan-B can be dispensed without a prescription to women over the age of 18, but is dispensed to women under the age of 18 only with a prescription. Accordingly, other medicines, such as the aforementioned oral contraceptive, have both a prescription and non-prescription classification. These dual status medicines are available only behind-the-counter of the pharmacy as certain criteria, such as age verification by the licensed practitioner, must be met before dispensing without a prescription.
Most countries regulate the distribution of medicines in a manner similar to the regulations for dispensing medicines in the United States discussed above.
For example, Australia utilizes a medicine distribution system that classifies the available distribution system into four different categories or schedules, namely Unscheduled, Schedule 4, Schedule 3, or Schedule 2. It should be noted that the term schedule as used in the Australian classifications system is not the same as that used under the U.S. system and referenced under U.S.C. 812 and the Controlled Substance Act.
In Australia, unscheduled medicines are general sale products that are available without prescription or interaction with a pharmacist and, thus, are typically available over-the-counter at any retail location. In contrast, medicines classified as Schedule 4 and Schedule 3 are located behind-the-counter, while Schedule 2 are located in front of the pharmacy counter. More particularly, medicines classified as “Schedule 4 medicines” are available by prescription only and are available for distribution from behind-the-counter by a pharmacist in a pharmacy location. Medicines classified as “Schedule 3 medicines” are available without a prescription (i.e., a non-prescription medicine), but can be supplied only by a pharmacist in a pharmacy location. Thus, Schedule 3 medicines are available for distribution from behind-the-counter to allow for the necessary pharmacist-patient interaction. Medicines classified as “Schedule 2 medicines” are available without a prescription, but may require advice from a pharmacist prior to dispensing. As such, Schedule 2 medicines are also available for distribution and access from in front-the-counter, and to provide the opportunity for a pharmacist-patient interaction at a pharmacy location only.
As another example, the United Kingdom utilizes a medicine distribution system that classifies the medicine into one of three categories, namely general sales, pharmacy sales, and prescription sales. As the name suggest, general sales medicines are available without prescription or need for any interaction with a pharmacist and, thus, are available over-the-counter in the general sales area of a retail outlet. Pharmacy sales are available without prescription, but provide a means for an interaction with a pharmacist and, thus, are available behind-the-counter of the pharmacy. Further, prescription sales are available only with a prescription and, thus, are only available behind-the-counter of the pharmacy.
As seen from the discussion above, the distribution of medicines is typically based on a classification system, which generally results in the medicine either being available without distribution restrictions over-the-counter, which does not require interaction with doctor or pharmacist, or being available with distribution restrictions behind-the counter, which requires interaction with a pharmacist, or other employee.
It has been determined by the present disclosure that the distinction between medicines available with restrictions “behind-the-counter” and those available with or without restriction “over-the-counter” is important to the retail outlet or merchant selling the medicine. More specifically, “over-the-counter” medicines without restrictions do not require licensed pharmacy sites or any interactions with an employee or pharmacist when being purchased by a purchaser. In contrast, “behind-the-counter” medicines and age restricted over the counter medicines do require interaction with an employee when being purchased by a purchaser.
In addition to regulations placed on medicines discussed in detail above, the distribution of many medical devices such as, but not limited to, hypodermic needles, HIV tests, certain orthopedic devices are also regulated. For example, many states require the sale of hypodermic needles to be made from behind-the-counter and/or only to persons over a predetermined age. In addition, some medical devices are only available with a prescription. Thus, access to many non-medicinal medical devices are faced with similar distribution difficulties discussed hereinabove.
Further, many products fall into a more general class of products referred to herein as “nutraceuticals”, which includes products such as, but not limited to, nutritional supplements, functional foods, dietary supplements, vitamins, botanicals, medical foods, and others. It is contemplated that one or more of the aforementioned and other nutraceuticals may have a restricted distribution status imposed thereon by a regulating body, by the manufacturer, by the retail outlet, and any combinations thereof.
In addition, the distinction between medical products available “behind-the-counter” and those available “over-the-counter” is important to the consumers who have a desire to use or select certain medical products. For instance, the over-the-counter medical products that do not require interaction with an employee and makes the medical products more easily obtainable by the consumer.
Accordingly, it has been determined by the present disclosure that there is a continuing need for systems and methods for dispensing medical products having a non-prescription status without the need for the additional access restraints and restrictions traditionally associated with such behind-the-counter and pharmacy sales only. Further, it has been determined by the present disclosure that there is a need for methods of switching prescription medical products to non-prescription status using an electronic vending machine as a means to aid, assist and restrict access to ensure the safe and effective use of such prescription products in an over-the-counter environment.
Further, it has been determined by the present disclosure that there is a continuing need for systems and methods for dispensing medicines having a non-prescription status without the need for the additional access restraints and restrictions by retailers who use physical barriers or place medical products and devices behind the counter or under the control of a sales employee in order to restrict access due to concerns of theft.